Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula

NCT06484660 | Recruiting

• 1 other identifier: IB4521/21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to study whether the minimally invasive approach in the mucosal advancement flap technique for the treatment of complex perianal fistula improves the healing rate compared to non-minimally invasive surgery. The main question it aims to answer is: \- Does the healing rate of patients undergoing minimally invasive approach in the mucosal advancement flap technique improve compared to patients undergoing non-minimally invasive surgery? Researchers will also compare minimally invasive approach in the mucosal advancement flap technique to the non-minimally invasive approach in terms of postoperative pain, fecal incontinence and healing time. Quality of life and global morbidity will also be analyzed. Participants will:

• Undergo surgical treatment of complex perianal fistula performed by mucosal advancement flap performed by a minimally invasive technique.
• Attend control visits and fill in symptom forms one week, one month, three months and six months after the surgical procedure.

Conditions

Fistula Perianal

Keywords

Perianal Fistula; Mucosal Advancement Flap; Minimally Invasive Approach

Outcome Measures

Primary Outcomes (1)

• Healing rate

  Healing will be measured if 4 criteria are present: no supuration or pain for more than a week, no open external fistulous orifice, no palpable trajectory, no internal fistulous orifice and no tract or collections in 3D endoanal ultrasound.

  six months

Secondary Outcomes (4)

• Postoperative pain

  one week

• Global morbidity

  one month

• Quality of life score

  six months

• Fecal incontinence

  six months

Study Arms (1)

Minimally Invasive Approach In The Mucosal Advancement Flap Technique

EXPERIMENTAL

Procedure: Minimally Invasive Approach In The Mucosal Advancement Flap Technique

Interventions

Minimally Invasive Approach In The Mucosal Advancement Flap Technique PROCEDURE

Surgical treatment of complex perianal fistula. Less tissue damage. Electrocoagulation source with 75% lower power. Better de-epithelialization of the intra-sphinteric tract. More precise closure of orifice. More consistent mucosal flap

Minimally Invasive Approach In The Mucosal Advancement Flap Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18.
• Present with a complex perianal fistula not surgically treated with curative intention.
• Present only one main fistulous tract.
• Mucosal advancement flap as the chosen technique for the treatment of the fistula.
• Patient has given informed consent to participate in the study.

You may not qualify if:

• Non-cryptoglandular internal fistulous orifice (IFO).
• Extrasphincteric fistula.
• Coexistence of anal fissure.
• Coexistence of hemorrhoids tributary to surgery.
• Coexistence of anal or rectal prolapse.
• Coexistence of inflammatory bowel disease.
• Coexistence of anal or colorrectal cancer.

Sponsors & Collaborators

• Hospital Son Llatzer: lead
• Fundació d'investigació Sanitària de les Illes Balears: collaborator

Study Sites (1)

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

RECRUITING

Central Study Contacts

Ignacio Fernández_Hurtado

CONTACT

+34871202000; ifernandez@hsll.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in General Surgery. Specialist in Digestive Surgery

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)